Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, discusses how the new once every 2-month injectable PrEP has shown potential to increase adherence among populations with the greatest need.
Pharmacy Times® interviewed Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, on how the long-acting injectable PrEP compares to oral PrEP in terms of efficacy and safety and whether pharmacists are able to administer this long acting injectable for patients.
Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy Times®. Joining me is Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, on the benefits of long-acting PrEP as another tool to fight HIV.
So Carl, how does the long-acting injectable PrEP compare to the standard oral PrEP regimen in terms of efficacy and safety?
Carl Schmid: Well, we already have a good tool to prevent HIV, and that's the oral PrEP, and that may be a good option. It's safe for most people, but you have to take it every single day. And that may not work for everyone and our uptake of PrEP is not where it should be, particularly amongst certain communities, like African Americans and Latinos, particularly gay men.
So we do have this new option, and on paper and in clinical trials, it shows that it cuts down on the number of HIV cases. And they did 2 big trials. One was for cisgender men and transgender women, and they found that compared to the oral PrEP, there were around 69% fewer HIV infections. For cisgender women, it was around 90% fewer infections.
So it's not because it may be superior medically or not—it really had to do with adherence, and people taking people may not take a drug every day, particularly since they're not sick. You usually take a drug when you're sick. And this is really to prevent HIV and people may not want to take a pill every single day. This is a once every 2-month injection, you do have to go to a provider to do it, you cannot do it yourself, and it's in your butt, but it really seems that it is more efficacious because of adherence. It may be a wonderful option for more and more people.
But I think it's all about choice—having more options out there. Not everyone may not want to go for a once every 2 months injection, and they may just want to stick with the pills—it's up to them.
Alana Hippensteele: Absolutely. As a follow up, are pharmacists able to administer this long acting injectable for patients as well?
Carl Schmid: Yeah, well, it really depends on the state and the pharmacy and the location, but that seems kind of ideal—instead of going into your medical provider, to actually have it done at a pharmacy. You're seeing more and more of these pharmacies have such clinics.
But you do need privacy to do it. It's more than just your flu shot, or your COVID-19 shot. Because you do have to pull down your pants, and it has to be injected. So, it depends on the clinic and depends on the pharmacy, and it really depends on state laws, and if they have the availability as well.
Alana Hippensteele: Right, absolutely. Why has uptake of the once-a-day pill version of PrEP been slow since it came to market about a decade ago?
Carl Schmid: Yeah, a decade is a long time. There are a lot of people taking PrEP, we're up to probably around 360,000 or more; that was last year. But the problem is it's not getting to all the populations that need it most—particularly gay, black and gay, Latino men, black women, and still a lot of white men and gay men are not taking it. So we have to do a better job. We need to get in the next couple of years—the goal is up to 50% of the people who need it. We're probably around 30% right now. So we still have several more 100,000 people who should take it.
PrEP is a pill that you have to take every single day, and people may not want to do that particularly, since they're not sick. And they may not want to take a pill when others are around. There's still so much stigma associated with HIV. They may be labeled a certain way, if someone’s saying, ‘Well, why are you taking PrEP,’ I think it could be the other way too. For some people, it's a sense of empowerment for themselves by taking PrEP, and by letting others know that they have PrEP, but that's not for all, and particularly women, I think they are very reluctant to take a drug to prevent HIV, and let their partners know about it because they may not want the other person to think that they think that they're at risk of being infected with HIV.
So, there's so many other things—there's a cost barrier to it. It was a brand name drug now there is generic, so it's a lot cheaper to insure, and so there was cost sharing associated with it. But now, this is just remarkable, thanks to the Affordable Care Act, it is a Grade A US Preventive Service Task Force preventative service recommendation, and because of that, all insurers have to cover it without cost sharing.
The other thing is you have to go for labs. You have to prove continuously that you're HIV negative, you have to check for bone and kidney issues, and STDs, and those are—you have to get a prescription, you have to go to the doctor, get a prescription by the provider. And so, those cost money. And now, if you have insurance, that should be no cost sharing, but that just became effective last year, and we're still having issues with insurers charging people for not only the drug, but for the labs as well.
But those are the some of the big reasons. And I think a lot of it has to do with providers. Well, first of all, people who need PrEP are not aware that it's out there, and providers don't prescribe it as well, particularly in the south, and there's just so much stigma. People don't talk about sex, people don't talk about gay people, gay sex, and a provider has to have that conversation with their patient and has to talk about all those issues before they can talk about PrEP, and a lot of providers just aren't doing it. So we need a lot more education, both for the community and providers.
Alana Hippensteele: Absolutely, absolutely. What are some of the ways that the long-acting injectable version of PrEP may diminish some of the experience of stigma for PrEP users?
Carl Schmid: Yeah, I mean, you don't have to have a drug and a bottle in your house. And no one has to know, in your household, that you're taking PrEP, the drug won't be delivered to you, even though I think they do make the drugs in unmarked boxes and bags. But people will still ask, especially if you don't want other people in the household to know that you're taking a drug, so you don't have to have the shipped to your house, and you can go to a clinic or your doctor, and just go every 2 months, and quickly, it shouldn't be less than 15 minutes. And I think that really helps us stigma. And it doesn't remind you every single day also, that you're possibly potentially at risk of HIV, and it just makes it a little easier. Again, it's not for everyone, but it's important to have that choice, and it should help reduce stigma.
Alana Hippensteele: Absolutely. PrEP is often understood to be very helpful for men who have sex with men. But what are some other populations that perhaps are less discussed as being that would benefit from having PrEP available to them that would also benefit from this long-acting injectable version as well?
Carl Schmid: Yeah, well, definitely women. Up until now, there's been 2 types of oral PrEP. The first one is now generic, but the second one was not tested on women in clinical trials. So it's only [emtricitabine and tenofovir disoproxil fumarate (Truvada; Gilead Sciences)] is indicated for women and not [emtricitabine and tenofovir alafenamide (Descovy; Gilead Sciences)]. But the long-acting PrEP is studied [for women]. There were separate drug trials for both cisgender men and transgender women and for cisgender women. So it's approved for all populations.
So it's definitely good for women. And also, for people who are homeless, for injection drug users who may not remember to take a drug every single day. So I think that could be other populations that could really benefit from a long-acting injectable.
Alana Hippensteele: Absolutely, absolutely. What needs to occur for insurance companies to fully cover long-acting injectable PrEP, as well as the standard oral regimen.
Carl Schmid: So right now, we're seeing a lot of insurance uptake of the long acting injectable. And already insurance plans have to cover the oral PrEP, at least one of them. But we find that many of the insurance plans cover all 3 of the oral, and they don't, they just have to have no cost sharing for at least one of them.
But if your provider says it's medically necessary that you take a certain PrEP that is not covered by your plan, you have to access that as well without cost sharing. So, we’re seeing good coverage of the oral PrEP, and we're now seeing pickup of long-acting PrEP as well by a lot of insurers. But it is recommended by the CDC in their clinical guidelines for PrEP. However, it's not yet incorporated in the US Preventive Service Task Force recommendation for PrEP. That is under review right now, as we speak, and hopefully in the next couple of months, we'll see their recommendation. And we're pretty confident that since this drug is superior to the existing oral PrEP, that they will incorporate this. So that will come out and it will be final, and then after that, insurers will be required to cover it without cost sharing.
But that could take some time, there's still some interpretation, we may need some further guidance from the federal government on what plans what they have to do and when. And we also would like to set up a system that just like smoking cessation drugs and contraception, that insurers—there's like 18 different types of contraception, and insurers are required to cover one of each type of contraception. And I think that's what we'd like to set up that same paradigm for long-acting PrEP and are with PrEP in general, that you have to cover an oral once a day, you have to cover an injection once every 2 months. But remember, we're just at the beginning stages of PrEP. I think there's going to be future long-acting PrEP out there as well. We don't want to go through this review process every time and wait, and then, give time for the insurance to cover it.
So some state there's actually some bills and in the Congress that say that insurance have to cover all forms of PrEP without cost sharing. Unfortunately, that's just a bill and it hasn't passed. But we do have that in some states, actually—California and Maine—they have to cover all PrEP drugs without cost sharing. So they don't have to wait in those states. So we're working with insurance commissioners, to also require that by the insurance regulators without a law being passed. So it takes time and, as I said, we hope to establish a system that all future PrEP drugs would be covered, but still a work in progress.
Alana Hippensteele: Absolutely.
Carl Schmid: What we don't want is insurance just to cover one PrEP drug, and not give people the option of different types of PrEP.
Alana Hippensteele: Yeah. Are there any additional barriers that may need to be overcome to ensure patients not only have insurance coverage of but also access to the long-acting injectable version of PrEP?
Carl Schmid: Yeah, I mean, even though we're seeing, insurance coverage, or it's even required for the oral insurers are still a charging people in cost sharing, particularly for the labs. So we're receiving lots of complaints from people around the country that they are being charged, and we're helping them even appealing to their insurer and then filing complaints with their insurance department in their state. We're also letting the federal government know about it as well.
It's not so much we're seeing it with the drug, we have that sometimes, but it's more of the lab tests and the office visits. So if we're seeing that with the oral PrEP that's been around, I imagine we'll have the same problems with the long acting as well. So we really need further awareness, enforcement, and holding the insurers accountable that they have to cover not only PrEP the drug, but also the lab cost and the provider visits as well.